Pharmacokinetics of Elinogrel in Healthy Volunteers and Patients With Mild, Moderate, and Severe Renal Impairment

An Open-label, Parallel-group Study to Determine the Single and Multiple Dose Pharmacokinetics of Elinogrel and Its Metabolite in Patients With Mild, Moderate, and Severe Renal Impairment Compared to Healthy Subjects

The purpose of the study is to determine the pharmacokinetics and safety of elinogrel and its metabolite in patients with mild, moderate, and severe renal impairment compared to healthy volunteers.

Study Overview

• Status: Terminated
• Conditions: Renal Impairment
• Intervention / Treatment: Drug: Elinogrel

Detailed Description

Multiple-dose, open-label parallel-group design in patients with mild, moderate or severe renal impairment and age (±7 years), sex and weight (±15% BMI) matched healthy subjects.

• mild renal impairment: CrCl from 50 to ≤80 ml/min
• moderate renal impairment: CrCl from 30 to <50 ml/min
• severe renal impairment: CrCl of <30 ml/min

• Study Type: Interventional
• Enrollment (Actual): 44
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55404
      • DaVita Clinical Research
  • Tennessee
    • Knoxville, Tennessee, United States, 37920
      • NOCR-Knoxville

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Able to understand and sign the written informed consent
• Subjects should have either normal renal function or have stable renal disease

Exclusion Criteria:

• History of heart disease
• Unstable or clinically significant other disorders such as respiratory, hepatic, metabolic, psychiatric or gastrointestinal disorder

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: A-Patients with mild renal impairment	Drug: Elinogrel; 100 mg elinogrel b.i.d. with aspirin q.d. for 7 days and aspirin alone for 4 days (Dose of aspirin is 81 mg in the US and 100 mg in Germany); Other Names: PRT060128
Experimental: B-Healthy subjects matched to Group A	Drug: Elinogrel; 100 mg elinogrel b.i.d. with aspirin q.d. for 7 days and aspirin alone for 4 days (Dose of aspirin is 81 mg in the US and 100 mg in Germany); Other Names: PRT060128
Experimental: C-Patients with moderate renal impairment	Drug: Elinogrel; 100 mg elinogrel b.i.d. with aspirin q.d. for 7 days and aspirin alone for 4 days (Dose of aspirin is 81 mg in the US and 100 mg in Germany); Other Names: PRT060128
Experimental: D-Healthy subjects matched to Group C	Drug: Elinogrel; 100 mg elinogrel b.i.d. with aspirin q.d. for 7 days and aspirin alone for 4 days (Dose of aspirin is 81 mg in the US and 100 mg in Germany); Other Names: PRT060128
Experimental: E-Patients with severe renal impairment	Drug: Elinogrel; 100 mg elinogrel b.i.d. with aspirin q.d. for 7 days and aspirin alone for 4 days (Dose of aspirin is 81 mg in the US and 100 mg in Germany); Other Names: PRT060128
Experimental: F-Healthy subjects matched to Group E	Drug: Elinogrel; 100 mg elinogrel b.i.d. with aspirin q.d. for 7 days and aspirin alone for 4 days (Dose of aspirin is 81 mg in the US and 100 mg in Germany); Other Names: PRT060128

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetics of elinogrel and its metabolite	The PK parameters calculated for both elinogrel and PRT060301 were: AUC0-12h, Cmax, and Tmax on Day 1/Day 7 and T1/2, RACC & CLR on Day 7; For elinogrel only, CLss/F and Vss/F were also calculated	7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety assessments will include vital signs, electrocardiograms and adverse events	Safety assessments consisted of collecting all adverse events (AEs), serious adverse events (SAEs), with their severity and relationship to study drug, and pregnancies, regular monitoring of hematology, blood chemistry and urinalysis performed at study center. Safety assessments also included periodic ECG evaluations, assessments of vital signs, physical condition, and body weight.	9 days
Measures of platelet function	Platelet aggregation using VerifyNOW P2Y12 assay and thrombi formation using Portola's proprietary PCA (Perfusion Chamber Assay).	7 days

Collaborators and Investigators

• Sponsor: Portola Pharmaceuticals
• Collaborators: Novartis
• Investigators: Study Director: Matthew W McClure, MD, Portola Pharmaceuticals Inc.

Study record dates

Study Major Dates

• Study Start: September 1, 2009
• Primary Completion (Actual): December 1, 2009
• Study Completion (Actual): December 1, 2009

Study Registration Dates

• First Submitted: September 16, 2009
• First Submitted That Met QC Criteria: September 24, 2009
• First Posted (Estimated): September 25, 2009

Study Record Updates

• Last Update Posted (Actual): August 4, 2023
• Last Update Submitted That Met QC Criteria: August 3, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Healthy; Renal impairment; Kidney dysfunction; Elinogrel
• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Renal Insufficiency
• Other Study ID Numbers: 07-115 / CPRT128A2104